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目前,国内生产乙肝诊断试剂有55个厂家的264个生产文号。其中未纳入批批检定的抗-HBs,HBeAg,抗-HBe,抗-HBc(试剂,根据生物制品管理规定和卫生部的要求,我所在1996年6月至1997年12月间对45个厂家4个品种的576批试剂及HBsAgEIA678批试剂进行第3个年度抽检。实际抽到40个厂
At present, the domestic production of hepatitis B diagnostic reagents 55 manufacturers 264 production number. Among them, anti-HBs, HBeAg, anti-HBe, and anti-HBc (reagents, which were not included in the batch test) were administered to 45 factories from June 1996 to December 1997 according to the requirements of the management regulations of biological products and the Ministry of Health 4 batches of 576 batches of reagents and HBsAgEIA678 batch reagents for the third annual sampling of the actual pumping 40 plants